MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2019-11-05 for LMA SUPREME SIZE 1.5 175015 manufactured by Teleflex Medical.
[182600294]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[182600295]
Customer reported the device broke in the patient's mouth during intubation. The device did not separate into two pieces, as the gastric tube was connecting it. It was reported the patient was bagged while a new device was prepared and intubated. No patient injury reported. Patient condition was reported as "fine".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681900-2019-00049 |
| MDR Report Key | 9279420 |
| Report Source | DISTRIBUTOR,FOREIGN,USER FACI |
| Date Received | 2019-11-05 |
| Date of Report | 2019-10-16 |
| Date of Event | 2019-10-09 |
| Date Mfgr Received | 2019-10-16 |
| Date Added to Maude | 2019-11-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | VICTORIA SANDLIN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer G1 | THE LARYNGEAL MASK COMPANY |
| Manufacturer Street | 6 BATTERY ROAD #07-02 |
| Manufacturer City | SINGAPORE 049909 |
| Manufacturer Country | SN |
| Manufacturer Postal Code | 049909 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LMA SUPREME SIZE 1.5 |
| Generic Name | LMA SUPREME |
| Product Code | CAE |
| Date Received | 2019-11-05 |
| Catalog Number | 175015 |
| Lot Number | LMCA2N |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | ATHLONE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-05 |